MAUDE Adverse Event Report: COOK INCORPORATED MICROPUNCTURE; INTRODUCER, CATHETER

Model Number G48002

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

Anesthesia was prepping patient for left arterial line insertion.During the procedure, the guidewire was not able to be advanced into the artery.The needle was able to be easily withdrawn, but the guidewire would not withdraw and then stretched out.Upon removal of the wire, it was noted that the wire was not intact.Ultrasound of radial artery was suspicious for a retained distal wire.After intended procedure was completed, attending surgeon explored the left radial artery and removed the guidewire.Foreign body was sent to pathology.Post procedure, patient with + left radial pulse and good collateral circulation.

• Brand Name: MICROPUNCTURE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 13059317
• MDR Text Key: 282625830
• Report Number: 13059317
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G48002
• Device Catalogue Number: MPIS-401-10.0-SC-SST
• Device Lot Number: 14269207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male
• Patient Weight: 24 KG
• Patient Race: White